Registration Dossier
Registration Dossier
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EC number: 908-570-0 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Primary mutagenicity screening of food additives currently used in Japan
- Author:
- Ishidate, M., Jr., Sofumi, T., Yoshikawa, K., Hayashi, M., Nohmi, T., Sawada, M. and Matsuoka, A.
- Year:
- 1 984
- Bibliographic source:
- Fd Chem. Toxic., 22, 623-636
Materials and methods
- Principles of method if other than guideline:
- Method: other: Ames; McCann and Yamasaki, 1975
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- IUPAC Name:
- sodium hydrogencarbonate
- Reference substance name:
- Sodium bicarbonate
- IUPAC Name:
- Sodium bicarbonate
- Details on test material:
- SOURCE: Samples were supplied by the Japanese Food Additives
Association, Tokyo, J.
PURITY: 99.9%
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: Not reported.
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: TA 92, 94, 98, 100, 1535, 1537
- Metabolic activation:
- with
- Test concentrations with justification for top dose:
- max. 10 mg/plate
- Details on test system and experimental conditions:
- - Ames test
- Species/cell type: S. typhimurium, TA 92, 94, 98, 100, 1535, 1537.
- Deficiences/Proficiences: his+
- Metabolic activation system: S9 mix, from livers of Fischer rats pretreated 5 days with polychlorinated biphenyls.
- Solvent: Phosphate buffer.
Results and discussion
Test results
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: not reported
- Remarks on result:
- other: other: TA 92, 94, 98, 100, 1535, 1537
Any other information on results incl. tables
GENOTOXIC EFFECTS:
- With metabolic activation: Negative.
- Without metabolic activation: Not performed.
PRECIPITATION CONCENTRATION: Not reported.
FREQUENCY OF EFFECTS: Not reported.
CYTOTOXIC CONCENTRATION:
- With metabolic activation:10 mg/plate.
- Without metabolic activation: Not performed.
TEST-SPECIFIC CONFOUNDING FACTORS: Not reported.
STATISTICAL RESULTS: Not reported.
Applicant's summary and conclusion
- Conclusions:
- Based on this test sodium carbonate does not induce mutation in bacteria (TA 92, 94, 98, 1535 and 1537) in presence of metabolic activation.
- Executive summary:
In a Ames test study performed on S. Typhimurium strains (TA 92, 94, 98, 100, 1535, 1537) in two replicates with metabolic activation no mutation was induced under the test condition.
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